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The Enceed T cell Activation, human (GMP) is used for in vitro activation and expansion of enriched T cells or peripheral blood mononuclear cells (PBMCs). Due to the nanoscale structure of Enceed T cell Activation, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.

產品概述

Product Description

The Enceed T cell Activation, human (GMP) is used for in vitro activation and expansion of enriched T cells or peripheral blood mononuclear cells (PBMCs). Due to the nanoscale structure of Enceed T cell Activation, human (GMP), the excess reagent can be removed by centrifugation or conventional supernatant replacement.

產品屬性

Capacity

Catalog number	Size	Capacity
L00935	4 mL	Up to 2×10⁸ enriched T cells or up to 4×10⁸ PBMCs in a maximal volume of 100 mL.

Components

Colloidal solution of iron-dextran nanoparticles conjugated to monoclonal CD3 antibody and CD28 antibody in PBS buffer stabilized with HSA and Poloxamer 188

Endotoxin Content

< 2 EU/mL as determined by Limulus Amebocyte Lysate (LAL) limit assay (USP <85>).

Sterility

Sterility is tested and confirmed according to USP <71>.

Storage & Stability

Store at 2-8 ℃.

Regulatory and legal notes

Disclaimer

Enceed T cell Activation, human (GMP) is for ex vivo cell processing only, and are not intended for human in vivo applications.
It is designed following the recommendations of USP <1043> on ancillary materials and the Guidance for CMC Research and Evaluation of Immune Cell Therapy Products (Trial Implementation) published by the National Medical Products Administration in China. It is manufactured and tested according to relevant GMP guidelines.

Warranty

The products sold hereunder are warranted only to be free from defects in workmanship and material at the time of delivery to the customer. GenScript makes no warranty or representation, either expressed or implied, with respect to the fitness of a product for a particular purpose. There are no warranties, expressed or implied, which extend beyond the Specification of the products.
GenScript's liability is limited to either replacement of the products or refund of the purchase price.
GenScript is not liable for any property damage, personal injury, or economic loss caused by the products.

Warnings and precautions

Warnings and precautions

1. Do not freeze.
2. The product is intended for in vitro use only. Not for intravenous infusion.
3. When using this product, the national legislation and regulations must be followed. Any application of ex vivo processed target cells is exclusively within the responsibility of the user.
4. Do not use after the expiry date printed on the product label.
5. Do not use it if the package is damaged. Use reagent only if the vial is undamaged and sealed.
6. Do not reuse.
7. The product is not recommended for use with patients known or suspected to have sensitivity against mouse immunoglobulins or iron-dextran.
8. Patients may develop human anti-mouse antibodies (HAMA).

Instructions for use

Instructions for use

1. The cell concentration and titer for stimulation of fresh PBMCs or enriched T cells are recommended in the following table. For optimal stimulation T cells should be activated with 1×10⁶ T cells per mL when used at recommended titer 1:25. For FPBMC optimal stimulation conditions are 2×10⁶ PBMCs per mL with a recommended titer 1:25.

Enriched T cells	Cell concentration	Titer
Optimum	1×10⁶ per mL	1:25
Maximum	2×10⁶ per mL	1:25

PBMCs	Cell concentration	Titer
Optimum	2×10⁶ per mL	1:25
Maximum	4×10⁶ per mL	1:25

2. When working with frozen material, it is recommended to rapidly thaw the cells, wash away the freezing solution containing DMSO, resuspend the cells in culture medium at densities below 5×10⁶ cells / mL, and rest the cells overnight at 37°C and 5% CO₂ in culture medium.
3. Presence of residual EDTA will hamper T cell stimulation1. Ensure removal of EDTA prior to T cell stimulation with Enceed T cell Activation, human (GMP) e.g.via a washing step.
4. Enceed T cell Activation, human (GMP) can be used in combination with Retro- or Lentiviral transduction. It is recommended to transduction T cells 2-3 days after stimulation.
5.Work under sterile conditions.
6. Remove the reagent from the vial manually or use an automated process.

圖例

產品編號	L00935
規格	4 ml 大單詢價
數量
價格	詢價


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Enceed? T cell Activation, human (GMP)

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